Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000571370
Ethics application status
Approved
Date submitted
1/09/2008
Date registered
12/11/2008
Date last updated
6/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
ENvironment and Vision Optimisation in Residential Care (EnVORC)
Scientific title
Effectiveness of vision intervention, environmental modification, and staff training targeting vision factors; to improve vision, independence, safety and quality of life in the residential care setting.
Secondary ID [1] 283531 0
nil known
Universal Trial Number (UTN)
Trial acronym
ENvironment and Vision Optimisation in Residential Care (EnVORC)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vision 3594 0
Physical environment in residential care facility/s 3595 0
Residents' Independence in residential care setting 3596 0
Safety in residential care setting 3597 0
Quality of Life in residential care setting 3598 0
Condition category
Condition code
Eye 3754 3754 0 0
Diseases / disorders of the eye
Mental Health 3755 3755 0 0
Depression
Injuries and Accidents 3756 3756 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implementation of a targeted intervention plans to address individuals' and facilities' environmental factors influencing vision and the environment to improve residents' safety, function and quality or life in participating facilities. Interventions include provision of magnification glasses, referral to optometrist/ opthalmologist/ general practitioner (GP), environmental modification of facility (eg improvement in lighting), and staff training related to vision and residential care (staff training was a one hour session of demonstration and experiential learning, supported with a resource kit for ongoing review.). The full intervention took approximately six months.
Intervention code [1] 3309 0
Other interventions
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4652 0
environmental hazards in residental care facilities and residents' bedrooms (Improving the environment for older people in health services audit tool - Victorian Department of Human Services)
Timepoint [1] 4652 0
baseline and post intervention
Primary outcome [2] 4653 0
Residents' quality of life as assessed on the "Nursing home, vision targeted, health related, quality of life questionnaire' (NHVQoL)
Timepoint [2] 4653 0
baseline and post intervention
Secondary outcome [1] 7867 0
Safety and Falls, as recorded by facilities' incident reports
Timepoint [1] 7867 0
baseline and post intervention
Secondary outcome [2] 8398 0
Residents' physical function as assessed on the deMorton Mobility Index (DEMMI)
Timepoint [2] 8398 0
baseline and post intervention
Secondary outcome [3] 8399 0
Residents' depression levels as assessed from the Cornell and Patient Health Questionnaire-9 (PHQ-9) scales
Timepoint [3] 8399 0
baseline and post intervention
Secondary outcome [4] 8400 0
Environmental audit, using the tool "Improving the environment for older people in health services: an audit tool"
Timepoint [4] 8400 0
baseline and post intervention

Eligibility
Key inclusion criteria
Resident of low care participating residential facility or high care resident within participating low care facility that has ageing in place.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not fitting inclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Individually tailored intervention based on participants' vision screening and environmental assessments.
Implementional of facility improvements based on environmental audit tool.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2008
Actual
25/02/2008
Date of last participant enrolment
Anticipated
Actual
29/04/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
189
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1124 0
3134
Recruitment postcode(s) [2] 1125 0
3228
Recruitment postcode(s) [3] 1126 0
3015

Funding & Sponsors
Funding source category [1] 3810 0
Government body
Name [1] 3810 0
Eye Health Demonstration Grants Program, Australian Government Department of Health and Ageing
Country [1] 3810 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Ageing Research Institute
Address
PO Box 2127
Royal Melbourne Hospital
Parkville 3050
Country
Australia
Secondary sponsor category [1] 3420 0
Charities/Societies/Foundations
Name [1] 3420 0
Centre for Eye Research Australia
Address [1] 3420 0
University of Melbourne
32 Gisborne St
East Melbourne 3002
Country [1] 3420 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5867 0
Barwon Health Research and Ethics Advisory Committee
Ethics committee address [1] 5867 0
Ethics committee country [1] 5867 0
Australia
Date submitted for ethics approval [1] 5867 0
Approval date [1] 5867 0
13/11/2007
Ethics approval number [1] 5867 0
07/81

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28869 0
Prof Keith Hill
Address 28869 0
National Ageing Research Institute Preventive and Public Health Division, Building 8, Gate 4, 34-54 Poplar Rd, Parkville, Victoria 3052
Country 28869 0
Australia
Phone 28869 0
+61 3 8387 2626
Fax 28869 0
Email 28869 0
[email protected]
Contact person for public queries
Name 12026 0
Professor Keith Hill
Address 12026 0
National Ageing Research Institute
Preventive and Public Health Division
PO Box 2127
Royal Melbourne Hospital 3050

or Gate 4, 34-54 Poplar Rd
Building 8
Country 12026 0
Australia
Phone 12026 0
+61 3 8387 2626
Fax 12026 0
+61 3 8387 2153
Email 12026 0
[email protected]
Contact person for scientific queries
Name 2954 0
Professor Keith Hill
Address 2954 0
National Ageing Research Institute
Preventive and Public Health Division
PO Box 2127
Royal Melbourne Hospital 3050

or Gate 4, 34-54 Poplar Rd
Building 8
Country 2954 0
Australia
Phone 2954 0
+61 3 8387 2626
Fax 2954 0
+61 3 8387 2153
Email 2954 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.